Background

Medical products are safer and more effective for everyone when clinical research includes diverse populations.

Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race and ethnicity) in applications for medical products – drugs, biologics and devices, submitted to the agency for marketing approval:

1) Are included in clinical trials; and
2) If subgroup-specific safety and effectiveness data are available.

Sec. 907 also required the FDA to provide Congress with an action plan detailing “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, health care professionals, and researchers” and to indicate the center(s) tasked with each recommendation. Congress directed the Agency to issue the action plan one year following the publication of the Sec. 907 report.

To fulfill these directives, FDA systematically evaluated sponsor applications, FDA reviews, and product labeling, and examined 72 medical products submitted to FDA for marketing approval in 2011. The agency published a final report on the investigation in August 2013. FDA accepted public comments to the report for 90 days and also held many other small group meetings with stakeholders. On April 1, 2014, FDA held a public hearing seeking input from stakeholders - including clinical researchers, industry, academia, health care providers and patient advocates on issues and challenges associated with the collection, analysis and availability of demographic subgroup data to inform the development of an action plan that is pragmatic and public health focused. Additionally, the original docket was reopened until May 16, 2014.

Action Plan Priority Areas

The Sec. 907 Action Plan thoughtfully considers public feedback, congress’s requirements, and the initial report’s findings. The plan outlines the agency’s current policies and practices, and presents 27 action items focused on three priorities:

1. Quality: to improve the completeness and quality of demographic subgroup data;
2. Participation: to identify barriers to subgroup enrollment in clinical trials and employ strategies to encourage greater participation;
3. Transparency: to improve the public availability of demographic subgroup data.

The FDA’s Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data reflects the Agency’s commitment to encourage the inclusion and greater representation of a diverse patient population in biomedical research leading to the development of medical products. Increasing representation is a multi-faceted challenge that will require collaboration of our federal partners, industry, health care professionals, patient advocacy groups and community-based organizations. We will continue to work with our stakeholders and continue the dialogue on this important issue. As we move forward with implementation of the Sec. 907 Action Plan, we will provide updates and progress on the action items to this webpage.